Are Human Genes Patentable? Student Recounts Arguments

Baltimore Fishbowl student intern Ethan Park had the privilege last week to hear attorneys argue the case over gene patents before the United States Supreme Court.

Recently, in the landmark case AMP v. MyriadGenetics, the justices of the U.S. Supreme Court have endeavored to resolve the question: Are human genes patentable?

Last year, the U.S. Court of Appeals for the Federal Circuit ruled that Myriad Genetics’ patents directed to the BRCA1 and BRCA2 genes, whose variants are associated with an increased risk of developing breast and ovarian cancer, are patentable subject matter.

The Association for Molecular Pathology (AMP) appealed to the Supreme Court, oral arguments were made just over a week ago before a packed courtroom, and a verdict is expected in June or July.

Patents expire 20 years from the filing date, and patent protection for the BRCA genes has given Myriad a monopoly over BRCA testing procedures, which brings in millions of dollars annually for the company. Myriad also has the right to deny competitors or individuals from further researching or producing the genes without their consent.

AMP argued the genes’ patent eligibility depends strictly on whether or not they are formed by nature or naturally-occurring processes. According to Supreme Court precedent, if the genes in question are products of nature, they are not patent eligible.

On the other hand, Myriad asserted that if the BRCA gene variants have been derived using human ingenuity and artificial processes, the patents protecting them are valid.

Whether or not the BRCA gene could be classified as a product of nature seemed to be the crux of the case, as the justices questioned the patent eligibility of items such as baseball bats and extracts from Amazon river plants. The justices’ questions showed that they were trying to determine when a product is considered naturally occurring versus when human intervention had transformed the product into a non-naturally occurring product.

Based on case law precedent, the Supreme Court may uphold the verdict that Myriad is entitled to its patent claims. However, if the Supreme Court were to rule Myriad’s patents as invalid, it would have an immediate effect on the biotechnology industry. Without the security of patent protections, there is concern that corporations like Myriad may not invest in expensive research that has the potential to advance science and healthcare.

Where do you stand?

Ethan Park is the Baltimore Fishbowl student intern. He is a sophomore at Gilman School.